03-26195. Pesticide Product Registrations; Conditional Approval

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces Agency approval of an application submitted by Interregional Research Project Number 4 (IR-4), New Jersey Agricultural Experiment Station, Technology Center, on behalf of the Arizona Cotton Research and Protection Council to conditionally register the pesticide product Aspergillus flavus AF36 containing a new active ingredient not included in any previously registered products pursuant to the provisions of section 3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended.

FOR FURTHER INFORMATION CONTACT:

Shanaz Bacchus, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111)
• Animal production (NAICS code 112)
• Food manufacturing (NAICS code 311)
• Pesticide manufacturing (NAICS code 32532)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket ID number OPP-2003-0323. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is [phone].

Legacy docket for this case is OPP-2003-0048, which was set up in connection with the Notice of receipt of an application to register the pesticide product Aspergillus flavus AF36 containing a new active ingredient not included in any previously registered product pursuant to the provisions of section 3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended.

In accordance with section 3(c)(2) of FIFRA, a copy of the approved label, the list of data references, the data and other scientific information used to support registration, except for material specifically protected by section 10 of FIFRA, are available for public inspection in the Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Rm. 119, Crystal Mall #2, Arlington, VA [phone]. Requests for data must be made in accordance with the provisions of the Freedom of Information Act and must be addressed to the Freedom of Information Office (A-101), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Such requests should: Identify the product name and registration number and specify the data or information desired.

A paper copy of the fact sheet, which provides more detail on this registration, may be obtained from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161.

2. Electronic access. You may access this Federal Register document electronically through the EPA internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr/​.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at: http://www.epa.gov/​edocket/​ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

II. Did EPA Conditionally Approve the Application?

A conditional registration may be granted under section 3(c)(7)(C) of FIFRA for a new active ingredient where certain data are lacking, on condition that such data are received by the end of the conditional registration period and do not meet or exceed the risk criteria set forth in 40 CFR 154.7; that use of the pesticide during the conditional registration period will not cause unreasonable adverse effects; and that use of the pesticide is in the public interest. The Agency has considered the available data on the risks associated with the proposed use of Aspergillus flavus AF36, and information on social, economic, and environmental benefits to be derived from such use. Specifically, the Agency has considered the nature and its pattern of use, application methods and rates, and level and extent of potential exposure. Based on these reviews, the Agency was able to make basic health and safety determinations which show that use of Aspergillus flavus AF36, during the period of conditional registration will not cause any unreasonable adverse effect on the environment, and that use of the pesticide is, in the public interest.

Consistent with section 3(c)(7)(C) of FIFRA, the Agency has determined that these conditional registrations are in the public interest. Use of the pesticides are of significance to the user community, and appropriate labeling, use directions, and other measures have been taken to ensure that use of the pesticides will not result in unreasonable adverse effects to man and the environment.

III. Conditionally Approved Registration

EPA issued a notice, published in the Federal Register of March 12, 2003 (68 FR 11841) (FRL-7293-8), which announced that Interregional Research Project Number 4 (IR-4), New Jersey Agricultural Experiment Station, Technology Center of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390, on behalf of the Arizona Cotton Research and Protection Council, 3721 East Weir Avenue, Phoenix, AZ 85040-2933, had submitted an application to register the pesticide product, Aspergillus flavus AF36, antifungal agent (EPA File Symbol 71693-R) containing Aspergillus flavus AF36 at 0.0008%, an active ingredient not included in any previously registered product.

EPA file symbol 71693-1: Aspergillus flavus AF36, a non aflatoxin-producing strain of Aspergillus flavus, is conditionally registered for use on cotton in Arizona and Texas to displace aflatoxin-producing strains of Aspergillus flavus.

The application was conditionally approved on June 24, 2003 for an end-use product manufactured by an integrated process:

Aspergillus flavus AF36 is conditionally registered for use on cotton in Arizona and Texas to reduce aflatoxin-producing colonies of Aspergillus flavus. The mammalian health effects and ecological effects data bases support the conditional approval of the pesticide. Soil and air monitoring studies were provided to demonstrate the efficacy of the product for the proposed uses in Arizona. Because the pesticide is to be used to reduce aflatoxin-producing strains of Aspergillus flavus, with a potential reduction of aflatoxin, a public health hazard, this pesticide qualifies for an automatic presumptive finding, and its use is presumed to be in the public interest. Aspergillus flavus AF36 was used for several years in an experimental use program without adverse effects. Conditions of registration include (a) analyses of 5 batches at production, (b) confirmation by high performance liquid chromatography (HPLC) that the strain does not produce aflatoxin, (c) polymerase chain reaction (PCR) analyses of the active ingredient to confirm product identity, and (d) efficacy (product performance) data to demonstrate the reduction of toxigenic strains by Aspergillus flavus AF36 in Texas. These data must be submitted within 30 months of the conditional registration date. Additional data will be required to support application of the pesticide to cotton in other states or to other food/feed commodities. An exemption from tolerance for residues of Aspergillus flavus AF36 on cotton was established in association with this conditional registration.

List of Subjects

• Environmental protection
• Chemicals
• Pesticides and pests

Dated: September 25, 2003.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.